Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 212157
Company: SCILEX PHARMS
Company: SCILEX PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ELYXYB | CELECOXIB | 25MG/ML | SOLUTION;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/05/2020 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212157s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212157Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212157Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/28/2021 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212157s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212157Orig1s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/28/2021 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212157s002lbl.pdf | |
04/28/2021 | SUPPL-2 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212157s002lbl.pdf | |
05/05/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212157s000lbl.pdf |